Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CHMP has recommended five medicines for approval at its March 2025 meeting, including two innovative drugs and three biosimilars.</li>
<li>The Committee Recommended not granting a marketing authorization for Eli Lilly’s Kisunla (donasemab), a medicine intended for the treatment of early Alzheimer’s disease.</li>
<li>The committee recommended extensions of indication for seven medicines that are already authorized in the EU, while recommended to refuse extending the marketing authorisation for Pemazyre for myeloid/lymphoid neoplasms.</li>
</ul>


CHMP has recommended five medicines for approval at its March 2025 meeting, including two innovative drugs and three biosimilars.
The Committee Recommended not granting a marketing authorization for Eli Lilly’s Kisunla (donasemab), a medicine intended for the treatment of early Alzheimer’s disease.
The committee recommended extensions of indication for seven medicines that are already authorized in the EU, while recommended to refuse extending the marketing authorisation for Pemazyre for myeloid/lymphoid neoplasms.


CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

<ul>
<li>Kissei Pharmaceutical initiates additional Phase III clinical trial for Rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Shanghai Junshi Biosciences received 11th indication approval for toripalimab in China.</li>
<li>AstraZeneca Entered into exclusive licensing agreement worth $1.35B with Alteogen to use latter’s hyaluronidase protein, ALT-B4, to develop subcutaneous versions of its “several oncology assets.”</li>
<li>Celltrion Has unveiled “Value-up Program,” whereby the company is targeting 30% revenue CAGR by 2027 to reach KRW5T revenue and 7% ROE. HLB faced another rejection from FDA for rivoceranib.</li>
</ul>


Kissei Pharmaceutical initiates additional Phase III clinical trial for Rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Shanghai Junshi Biosciences received 11th indication approval for toripalimab in China.
AstraZeneca Entered into exclusive licensing agreement worth $1.35B with Alteogen to use latter’s hyaluronidase protein, ALT-B4, to develop subcutaneous versions of its “several oncology assets.”
Celltrion Has unveiled “Value-up Program,” whereby the company is targeting 30% revenue CAGR by 2027 to reach KRW5T revenue and 7% ROE. HLB faced another rejection from FDA for rivoceranib.


APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

Technical Analyst, Vermilion Research

Joe Jasper

Technical Analyst

Technical and Quantitative Research

Vermilion Research

Vermilion’s objective is to deliver timely, actionable, and unique technical research to professional investors through the application of our various technical indicators.

Our research strategists seek to highlight securities which we believe are at major inflection points, based on our various technical and quantitative indicators, and offer asymmetric risk/return profiles. Our unique research methodology, centered on relative strength, enables our strategists to deliver superior investment recommendations.

Our process begins by organizing the universe of actively traded stocks into discrete sectors, then into industry groups. We then apply our technical and quantitative tools to identify developing price trends. Once attractive trends are identified within a selected sector or group, we screen for individual stocks which we believe offer the best risk/reward profile. We provide a historical perspective that often reveals, through our long-term charts, how price patterns often repeat themselves over time.

Technical Analysis

<ul>
<li>Our long-term outlook remains bullish as long as the S&amp;P 500 remains above 5770-5850 and 5600-5670 (worst case), and we are buyers at these levels.</li>
<li>With that said, we see potential for near-term downside based on several developments discussed below.  It likely means at least another 2-4 weeks of consolidation</li>
<li>If SPX remains below 6100 and 6150 resistances, do not be surprised if there is a test of the bottom of the range at either 5770-5850 or 5600-5670</li>
</ul>


Our long-term outlook remains bullish as long as the S&amp;P 500 remains above 5770-5850 and 5600-5670 (worst case), and we are buyers at these levels.
With that said, we see potential for near-term downside based on several developments discussed below.  It likely means at least another 2-4 weeks of consolidation
If SPX remains below 6100 and 6150 resistances, do not be surprised if there is a test of the bottom of the range at either 5770-5850 or 5600-5670


Near-Term Downside Likely Following False Breakouts; Targeting 5770-5850; Long-Term Still Bullish

<ul>
<li>In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.</li>
<li>The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.</li>
<li>Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.</li>
</ul>


In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.
The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.
Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.


CHMP Meeting Update: Eight New Medicines Recommended For Approval

<ul>
<li>Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.</li>
<li>Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.</li>
<li>Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.</li>
</ul>


Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.
Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.
Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.


APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

United Kingdom

AstraZeneca is a multinational pharmaceutical and biotechnology company that researches, develops, and manufactures prescription medicines. The company focuses on core therapeutic areas including oncology, cardiovascular, renal and metabolic diseases, respiratory and immunology, and rare diseases. It was founded in 1999 and is headquartered in Cambridge, UK.

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AstraZeneca (AZNN MM)

CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

Tina Banerjee

APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...

Tina Banerjee

Near-Term Downside Likely Following False Breakouts; Targeting 5770-5850; Long-Term Still Bullish

Near-Term Downside Likely After False Breakouts $SPX $QQQ; Long-Term Still Bullish; Major Tops on $DXY, 10-Year Treasury Yield. If < 6100 and 6150...

Vermilion Research

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

Tina Banerjee

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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52-week Range

Market Cap (USDm)

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CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

​CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

Tina Banerjee

APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

​Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...

Tina Banerjee

Near-Term Downside Likely Following False Breakouts; Targeting 5770-5850; Long-Term Still Bullish

Near-Term Downside Likely After False Breakouts $SPX $QQQ; Long-Term Still Bullish; Major Tops on $DXY, 10-Year Treasury Yield. If < 6100 and 6150...

Vermilion Research

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

Tina Banerjee

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...